红花逍遥片治疗肝郁气滞血瘀型月经后期的临床观察

Clinical Observation of Honghua Xiaoyao Tables in the Treatment of Delayed Menstrual Cycle of Liver-depression and Qi-blood Stagnation

目的:评价红花逍遥片治疗肝郁气滞血瘀型月经后期的疗效与安全性。方法:采用随机、双盲、双模拟、阳性药和安慰剂平行对照的多中心研究,将144例受试者按随机数字表法分成试验组72例、阳性对照组36例和安慰剂组36例。试验组患者服用红花逍遥片,阳性对照组患者服用女金片,安慰剂组患者服用模拟片,疗程均为8周,经期停药。结果:治疗后,在主要疗效(月经后期疗效)方面,试验组患者优于阳性对照组,但差异无统计学意义(P>0.05),且显著优于安慰剂组,差异有统计学意义(P<0.05);在次要疗效[中医证候疗效、中医各单项证候疗效(除经色经质、烦躁易怒外)等]方面,试验组患者均优于阳性对照组和安慰剂组,组间比较差异具有统计学意义(P<0.05)。治疗期间3组患者均未见不良事件发生。结论:红花逍遥片治疗肝郁气滞血瘀型月经后期安全、有效。

OBJECTIVE：To evaluate the efficacy and safety of Honghua xiaoyao tables in the treatment of delayed menstrual cycle of liver-depression and qi-blood stagnation.METHODS：In a randomized,double blind,double-dummy,positive drug and placebo parallel controlled,multicenter clinical trial,144 subjects were enrolled and randomly divided into trial group（72 cases）,positive control group（36 cases）and placebo group（36 cases）.Trial group was treated with Honghua xiaoyao tables,and positive control group was given Nvjin tables.Treatment course lasted for 8 weeks,and they stopped taking drugs during menstrual period.RESULTS：After treatment,main therapeutic efficacy（delayed menstrual cycle）of trial group was better than that of positive control group,without statistical significance（P〉0.05）;that of trial group was significantly better than that of placebo group,with statistical significance（P〈0.05）.In the field of secondary therapeutic efficacy [TCM syndrome efficacy,therapeutic efficacy of each TCM syndrome（excpet menstrual colour and property,irritable）,etc],trial group was better than positive group and placebo group,with statistical significance（P〈0.05）.No ADR was found in 3 groups during treatment.CONCLUSIONS：Honghua xiaoyao tables has been proved to be safe and effective in the treatment of delayed menstrual cycle of liver-depression and qi-blood stagnation.